MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I20-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was treated with afx.During a routine follow-up, a type ia was identified.In addition, aaa sac growth was observed.The patient underwent treatment on (b)(6) 2018; coils which resolved the reported type ia endoleak.The patient condition post treatment is reported as stable.
Additional Manufacturer Narrative
Based on the information received at the completion of the clinical evaluation, clinical was unable to confirm the following reported case event: type ia endoleak; sac growth; secondary endovascular procedure; and coils placed due to the lack of medical information available.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the proximal loss of seal was the concomitant use with the products outside the ifu, most likely due to the off-label neck anatomy.Procedure related harms and final patient disposition could not be ascertained due to the lack of medical information surrounding the initial implant procedure and the secondary endovascular procedure.Reportedly, the patient is in stable condition post the repair procedure.To date there has been no reports of further negative patient sequalae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7428968
• Report Number: 2031527-2018-00327
• Device Sequence Number: 1977030
• Product Code: MIH
• UDI-Device Identifier: 00818009014832
• UDI-Public: (01)00818009014832(17)180531
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: BEA25-70/I20-30
• Device Catalogue Number: F00820-100
• Device Lot Number: 1699040007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT 1627285012; VELA SUPRARENAL, LOT 1726317001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR